Description

Brivaracetam Impurity 21 is a designated impurity standard used in the analytical profiling and quality control of the antiepileptic drug Brivaracetam. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Brivaracetam API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for impurity characterization reports required for regulatory filings (e.g., with FDA, EMA).
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and controlling process-related impurities.

Basic Information

Product Name	Brivaracetam Impurity 21
CAS No.	63095-60-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brivaracetam Related Compound 21; (2S)-2-[(4R)-2-Oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide; UNII-8V6C8X7U4Q; 1-[(2S)-1-Aminocarbonylpropyl]-4-propyl-2-pyrrolidinone; Brivaracetam EP Impurity G; A potential impurity of Brivaracetam
EINECS	Contact for details

Quality Control

Our Brivaracetam Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, and impurity profile is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.